Molecular Templates, Inc. Reports Second Quarter 2024 Financial Results and Corporate Update
2024年8月15日 - 5:21AM
Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular
Templates,” or “MTEM”), a clinical-stage biopharmaceutical company
focused on the discovery and development of proprietary targeted
biologic therapeutics, engineered toxin bodies (“ETBs”), to create
novel therapies with potent differentiated mechanisms of action,
today reported financial results and business updates for the
second quarter of 2024.
“ETBs can eliminate immune cells that monoclonal antibodies
cannot. Eliminating MDSCs with MT-6402 and Tregs with MT-8421 is a
novel approach to immuno-oncology that is demonstrating durable
responses in patients who have progressed or were refractory to
checkpoint therapy. The elimination of immunosuppressive cells in
patients with tumor microenvironments that promote immune evasion
may drive long-lasting responses in patients who have exhausted
other treatment options,” said Eric Poma, PhD., Chief Executive and
Chief Scientific Officer of MTEM. “Similarly, we believe MT-0169
can eliminate CD38+ immune cells that antibodies cannot, allowing
for potentially greater potency in both hematologic malignancies
and autoimmune diseases.”
Recent Company Highlights
-
MT-6402: Continued monotherapy activity in patients who
progressed or were refractory to checkpoint therapyNine
patients (seven evaluable) with low PD-L1+ HNSCC were dosed in the
MT-6402 phase I dose escalation study. Two patients remain in
partial responses at cycle 23 and cycle 14 (one cycle is 4 weeks).
Both patients had progressed after multiple lines of checkpoint
therapy. In the high PD-L1+ dose expansion cohort, four NSCLC
patients (three evaluable) have been enrolled. and one patient is
in a partial response at cycle 11; the patient had progressed on
chemotherapy, targeted therapy, and checkpoint therapy. All
responding patients were heavily pretreated (3 or more lines of
previous therapy including checkpoint) and have been on MT-6402
longer than any other previous therapy. MTEM continues to enroll
HNSCC patients with low PD-L1 expression (1-49%) and patients with
solid tumors with high PD-L1 expression (≥50%).
-
MT-8421: Enrollment in Phase 1 dose escalation ongoing with
continued observation of unique pharmacodynamic profile (peripheral
and TME Treg depletion) and signs of monotherapy
activityFive melanoma patients were evaluable in the first
two dose cohorts (32 and 48 mcg/kg); no drug related adverse events
> grade 2 were observed. One patient remains on study in cycle
11 with a 27% decrease in tumor volume and reduction in circulating
tumor DNA from 3.13 to 0 MTM/mL. This patient had a >90%
reduction in peripheral Tregs and a ~66% reduction of Tregs in the
TME. The patient had progressed on pembrolizumab in the adjuvant
setting and then progressed on ipilimumab (4 doses at 3mg/kg) and
nivolumab in the metastatic setting.
-
MT-0169: Potential in severe autoimmune diseases being
explored based on clinical demonstration of complete elimination of
CD38+ immune cells at dose levels with no drug-related adverse
events > grade 2. The potent and unique mechanism of
action of MT-0169 is not subject to resistance mechanisms
associated with monoclonal antibodies like trogocytosis and can
eliminate high-expressing CD38 immune cells like plasma cells as
well as low-expressing CD38+ cells like HLA-DR CD38+ T-cells. This
mechanism of action does not require conditioning therapy. MTEM
will continue to develop MT-0169 in hematologic malignancies and is
evaluating the potential of MT-0169 in severe immune-mediated
diseases.
Upcoming Milestones for 2H 2024
- Additional updates from the MT-6402 low PD-L1+ HNSCC and high
PD-L1+ solid tumor expansions studies in 3Q24.
- Additional updates from the MT-8421 dose escalation study in
3Q24.
- MT-0169 Phase 1 study initiation in CD38+ hematological
malignancies and continued evaluation in autoimmune disease.
Upcoming Conferences
MTEM will participate at the H.C. Wainwright 26th Annual Global
Investment Conference taking place at the New York Lotte Palace
Hotel, September 9 – 11, 2024. An on-demand presentation will be
accessible virtually starting 7:00am ET September 9, 2024 via MTEM
corporate website. One-on-one meetings may be scheduled by directly
contacting MTEM.
Second Quarter 2024 Financial
Results
The net loss attributable to common shareholders
for the second quarter of 2024 was $8.1 million, or $1.23 per basic
and diluted share. This compares with a net loss attributable to
common shareholders of $10.9 million, or $2.89 per basic and
diluted share, for the same period in 2023.
Revenues for the second quarter of 2024 were $0.6 million,
compared to $6.9 million for the same period in 2023.
Total research and development expenses for the second quarter
of 2024 were $5.4 million, compared with $13.4 million for the same
period in 2023. Total general and administrative expenses for the
second quarter of 2024 were $3.5 million, compared with $5.2
million for the same period in 2023.
As of June 30, 2024, MTEM’s cash and cash equivalents totaled
$9.7 million. The Company expects that its cash and cash
equivalents for the quarter ended June 30, 2024 will support its
ongoing operations into the fourth quarter of 2024.
Molecular Templates, Inc.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(in
thousands, except share and per share
data)(unaudited) |
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Research and development revenue |
|
$ |
189 |
|
|
$ |
6,627 |
|
|
$ |
11,113 |
|
|
$ |
40,254 |
|
Grant revenue |
|
|
383 |
|
|
|
238 |
|
|
|
545 |
|
|
|
3,240 |
|
Total revenue |
|
|
572 |
|
|
|
6,865 |
|
|
|
11,658 |
|
|
|
43,494 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,402 |
|
|
|
13,413 |
|
|
|
12,807 |
|
|
|
32,455 |
|
General and administrative |
|
|
3,466 |
|
|
|
5,195 |
|
|
|
7,197 |
|
|
|
10,997 |
|
Total operating expenses |
|
|
8,868 |
|
|
|
18,608 |
|
|
|
20,004 |
|
|
|
43,452 |
|
Income/(loss) from
operations |
|
|
(8,296 |
) |
|
|
(11,743 |
) |
|
|
(8,346 |
) |
|
|
42 |
|
Interest and other income,
net |
|
|
130 |
|
|
|
365 |
|
|
|
239 |
|
|
|
820 |
|
Interest and other expense,
net |
|
|
(38 |
) |
|
|
(1,189 |
) |
|
|
(69 |
) |
|
|
(2,584 |
) |
Gain on extinguishment of
debt |
|
|
— |
|
|
|
1,795 |
|
|
|
— |
|
|
|
1,795 |
|
Change in valuation of contingent
value right |
|
|
107 |
|
|
|
303 |
|
|
|
651 |
|
|
|
303 |
|
Loss on disposal of property and
equipment |
|
|
— |
|
|
|
(399 |
) |
|
|
— |
|
|
|
(399 |
) |
Net loss attributable to common
stockholders |
|
$ |
(8,097 |
) |
|
$ |
(10,868 |
) |
|
$ |
(7,525 |
) |
|
$ |
(23 |
) |
Net loss per share attributable
to common stockholders: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(1.23 |
) |
|
$ |
(2.89 |
) |
|
$ |
(1.26 |
) |
|
$ |
(0.01 |
) |
Weighted average number of shares
used in net loss per share calculations: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
6,557,295 |
|
|
|
3,756,711 |
|
|
|
5,965,781 |
|
|
|
3,756,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Molecular Templates, Inc.CONDENSED
CONSOLIDATED BALANCE SHEETS(in thousands, except
share and per share data) |
|
|
|
June 30,2024(unaudited) |
|
December 31,2023 |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,657 |
|
|
$ |
11,523 |
|
Prepaid expenses |
|
|
787 |
|
|
|
2,195 |
|
Grants revenue receivable |
|
|
795 |
|
|
|
250 |
|
Other current assets |
|
|
777 |
|
|
|
2,804 |
|
Total current assets |
|
|
12,016 |
|
|
|
16,772 |
|
Operating lease right-of-use assets |
|
|
8,124 |
|
|
|
9,161 |
|
Property and equipment, net |
|
|
5,238 |
|
|
|
7,393 |
|
Other assets |
|
|
1,319 |
|
|
|
2,057 |
|
Total assets |
|
$ |
26,697 |
|
|
$ |
35,383 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,773 |
|
|
$ |
1,523 |
|
Accrued liabilities |
|
|
2,270 |
|
|
|
4,279 |
|
Deferred revenue, current |
|
|
— |
|
|
|
9,031 |
|
Other current liabilities |
|
|
2,637 |
|
|
|
2,488 |
|
Total current liabilities |
|
|
7,680 |
|
|
|
17,321 |
|
Operating lease liabilities, long term portion |
|
|
8,390 |
|
|
|
9,742 |
|
Contingent value right liability |
|
|
2,051 |
|
|
|
2,702 |
|
Other liabilities |
|
|
1,465 |
|
|
|
1,406 |
|
Total liabilities |
|
|
19,586 |
|
|
|
31,171 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.001 par value per share: |
|
|
|
|
|
|
Authorized: 2,000,000 shares as of June 30, 2024 and
December 31, 2023; Issued and outstanding: 250 shares as of
June 30, 2024 and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value per share: |
|
|
|
|
|
|
Authorized: 150,000,000 shares as of June 30, 2024 and
December 31, 2023; Issued and outstanding: 6,583,880 and
5,374,268 shares as of June 30, 2024 and December 31,
2023, respectively |
|
|
7 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
467,521 |
|
|
|
457,099 |
|
Accumulated deficit |
|
|
(460,417 |
) |
|
|
(452,892 |
) |
Total stockholders’ equity |
|
|
7,111 |
|
|
|
4,212 |
|
Total liabilities and stockholders’ equity |
|
$ |
26,697 |
|
|
$ |
35,383 |
|
|
Second tranche of July 2023 Private
Placement
We closed the second tranche of the July 2023 Private Placement
on April 2, 2024 with gross proceeds of approximately $9.5M. The
Company intends to use the net proceeds from the second tranche to
fund its ongoing clinical studies, working capital and for general
corporate purposes.
About Molecular Templates
Molecular Templates is a clinical-stage biopharmaceutical
company focused on the discovery and development of next-generation
ADCs. Our drug platform technology, known as Engineered Toxin
Bodies (ETBs), leverages the resident biology of a genetically
engineered toxin payload to create novel therapies with potent and
differentiated mechanisms of action for cancer and various disease
indications.
Forward-Looking
Statements
This press release contains forward-looking statements for
purposes of the Private Securities Litigation Reform Act of 1995
(the “Act”). Molecular Templates disclaims any intent or obligation
to update these forward-looking statements and claims the
protection of the Act’s Safe Harbor for forward-looking statements.
All statements, other than statements of historical facts, included
in this press release, including, but not limited to those
regarding strategy, future operations, the Company’s ability to
execute on its objectives, prospects, plans, future clinical
development of the Company’s product candidates, any implication
that the preliminary results, interim results, or the results of
earlier clinical trials or ongoing clinical trials will be
representative of the results of future or later clinical trials or
final results, the potential benefits, safety or efficacy and any
evaluations or judgments regarding the Company’s product
candidates, and future execution of corporate goals. In addition,
when or if used in this press release, the words “may,” “could,”
“should,” “continue”, “anticipate,” “potential”, “believe,”
“estimate,” “appears”, “expect,” “intend,” “plan,” “predict” and
similar expressions and their variants, as they relate to Molecular
Templates may identify forward-looking statements. Forward-looking
statements are not guarantees of future performance and involve
risks and uncertainties. Actual events or results may differ
materially from those discussed in the forward-looking statements
as a result of various factors including, but not limited to the
following: the continued availability of financing on commercially
reasonable terms, whether Molecular Templates’ cash resources will
be sufficient to fund its continuing operations; the results of
MTEM’s ongoing clinical studies and the ability to effectively
operate MTEM, and those risks identified under the heading “Risk
Factors” in Molecular Templates’ filings with the Securities and
Exchange Commission (the “SEC”), including its Form 10-Q for the
second quarter year ended June 31, 2024 and any subsequent reports
filed with the SEC. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Molecular
Templates specifically disclaims any obligation to update any
forward-looking statement, whether because of new information,
future events or otherwise.
Contacts:Grace Kimgrace.kim@mtem.com
Molecular Templates (NASDAQ:MTEM)
過去 株価チャート
から 7 2024 まで 8 2024
Molecular Templates (NASDAQ:MTEM)
過去 株価チャート
から 8 2023 まで 8 2024